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The Correlation Between Ovarian Function and Serum Biomarkers

ConditionsPremature Ovarian InsufficiencyDiminished Ovarian ReserveBiomarkerCopperCeruloplasminAging
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-45
SponsorShi Yun

About this trial

The goal of this observational study is to find differences in serum biomarkers between ovarian function and normal individuals.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

The selection criteria for healthy individuals are follows.

women aged 18-45.

Basic FSH<10IU/L, and AMH is within the normal range.

Regular menstruation.

Disqualifiers

Patients with congenital gonadal developmental abnormalities or a family history similar to "early menopause".

Patients with acquired organic lesions or decreased ovarian function caused by ovarian surgery.

Patients who have undergone artificial cycle therapy with Western medicine or other endocrine treatments within the past three months.

Patients with severe primary diseases and mental disorders such as crdiovascular, cerebrovascular, liver, kidney, and hematopoietic system.

Trial population

Visited the gynecology clinic of Dongzhimen Hospital from November 2023 to October 2024. Upon examination of sexual hormones or AMH, it was considered that patients with Diminished Ovarian Reserve (DOR), premature ovarian insufficiency (POI), and healthy individuals had decreased ovarian reserve function.

Trial design

Design model

Cohort

Time perspective

Cross-sectional

Treatments tested in this trial

  • blood test

    Diagnostic test

    Detection of serum levels of copper ions, iron ions, ceruloplasmin (CP), CuZn SOD, malondialdehyde (MDA), etc. Blood samples will be retained from the rest samples for sex hormones samples for testing sex hormones, which don't increase times of blood collection.

Treatment groups

35 Participants
are divided into 3 treatment groups
Group A: Diminished Ovarian Reserve Group1 intervention
Group B: Premature Ovarian Insufficiency Group (POI)1 intervention
Group C: Control Group1 intervention

Trial outcomes

Primary outcomes

1

copper

the level of copper in blood sample

Time frame
On the 2~4th day of menstruation (amenorrhea patients on the enrolled week)
2

Iron ion

the level of Iron ion in blood sample

Time frame
On the 2~4th day of menstruation (amenorrhea patients on the enrolled week)
3

ceruloplasmin, CP

the level of ceruloplasmin in blood sample

Time frame
On the 2~4th day of menstruation (amenorrhea patientson the enrolled week)
4

CuZn-Superoxide Dismutase, CuZn-SOD/SOD1

the level of CuZn-SOD/SOD1 in blood sample

Time frame
On the 2~4th day of menstruation (amenorrhea patients on the enrolled week)

Secondary outcomes

1

other relative biomarkers about copper/iron metabolism and oxidative stress

depending on the results of the five biomarkers above

Time frame
On the 2~4th day of menstruation (amenorrhea patients on the enrolled week)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shi Yun

Lead sponsor

Dongzhimen Hospital, Beijing

Sponsor institution

Source ClinicalTrials.gov
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